The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Monolisa Anti-hav Igm Eia.
| Device ID | K063319 |
| 510k Number | K063319 |
| Device Name: | MONOLISA ANTI-HAV IGM EIA |
| Classification | Hepatitis A Test (antibody And Igm Antibody) |
| Applicant | Bio-Rad Laboratories 3 BD RAYMOND POINCARE MARNES-LA-COQUETTE Hauts-de-seine, FR 92430 |
| Contact | Manuela Kaul |
| Correspondent | Manuela Kaul Bio-Rad Laboratories 3 BD RAYMOND POINCARE MARNES-LA-COQUETTE Hauts-de-seine, FR 92430 |
| Product Code | LOL |
| CFR Regulation Number | 866.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-02 |
| Decision Date | 2007-05-03 |
| Summary: | summary |